A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Air Challenge
研究概览
简要总结
The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be at least 18 years of age;
- •provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •sign a Confidentiality Disclosure Agreement (CDA);
- •be in good general health as determined by the Investigator/designee;
- •agree not to participate in any other oral/dental product studies during the course of this study;
- •agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
- •agree to refrain from the use of any non-study oral hygiene products*;
- •exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
- •have an absence of extensive calculus above the gum line;
- •agree to return for all scheduled visits and follow study procedures; and
- •have two teeth with a Schiff sensitivity score > 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)
排除标准
- •having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;
- •chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;
- •any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;
- •dental prophylaxis within 2 weeks prior to Baseline visit;
- •having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;
- •having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months;
- •having teeth or periodontium with pathology or defects likely to cause pain;
- •having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics;
- •self-reported pregnancy or lactation;
- •having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
- •history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
- •any diseases or condition that might interfere with the safe participation in the study;
- •inability to undergo study procedures;
- •having severe xerostomia;
- •having had active caries within the 12 months;
- •having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion;
- •teeth will be excluded from study measurements if they:
- •have deep, defective, or facial restorations;
- •have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
- •present with tendency for spontaneous bleeding;
- •have been scaled/root planed or restored within the past 3 months.
研究组 & 干预措施
Marketed stannous fluoride toothpaste
Brush twice daily
干预措施: Stannous fluoride toothpaste (Drug)
Marketed potassium nitrate toothpaste
Brush Twice Daily
干预措施: Potassium nitrate toothpaste (Drug)
Marketed sodium monofluorophosphate toothpaste
Brush Twice Daily
干预措施: Sodium monofluorophosphate toothpaste (Drug)
Experimental dipotassium oxalate toothpaste
Brush Twice Daily
干预措施: Dipotassium oxalate toothpaste (Device)
结局指标
主要结局
Air Challenge
时间窗: 4 weeks
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
次要结局
- Baseline Air Challenge(Baseline)
- Baseline Yeaple Probe(Baseline)
- Air Challenge(11 weeks)
- Tactile Threshold(11 weeks)